Michael J. Fox Foundation Commits up to $10 Million for Pre-Clinical Drug Development Under Therapeutics Development Initiative

April 01,2008

NEWYORK, NY — The Michael J. Fox Foundation for Parkinson’s Research seeks applications from industry and academic researchers for its $10-million 2008 Therapeutics Development Initiative (TDI). The program, first launched in 2006, is exclusively focused on stimulating the pre-clinical drug development research required to keep potential new therapies moving forward toward clinical testing — a key tactic in the Foundation’s mission to do whatever it takes to speed development of transformative treatments for Parkinson’s disease.

“The development of life-changing treatments requires that basic science discoveries be actively and aggressively pursued toward clinical testing,” said Katie Hood, CEO of The Michael J. Fox Foundation. “MJFF targets its resources to keep scientific solutions for PD moving toward pharmacy shelves as quickly and efficiently as possible. TDI works at the critical pre-clinical stage to prevent any promising novel treatment approach from stalling for lack of financial resources, expertise or focus.”

Years of basic research in cell-based studies and animal models have uncovered numerous promising biological targets that show initial promise to impact the symptoms and progression of Parkinson’s disease. But translating these fundamental discoveries into practical treatments requires focused and concerted effort to identify and optimize realistic strategies for eventual human testing.

Originally, TDI was designed exclusively to support and bolster industry-focused efforts on Parkinson’s research. TDI is part of MJFF’s focus on‘de-risking’ preclinical PD research for biotech and pharmaceutical companies, thus expanding and catalyzing industry investments in Parkinson’s drug development. By adding MJFF resources to companies’ own, the Foundation aims to make Parkinson’s therapies a more attractive bet and help to push research further along the pipeline.

For this new round of TDIawards, however, the Foundation has created a special funding track for academic researchers. Academic institutions, which historically have conducted the lion’s share of the basic research needed to identify drug targets, are increasingly engaging in translational efforts and in possession of the core resources and expertise required to conduct this work. Some have established sophisticated drug discovery programs entirely focused on the highly specialized studies required to keep hits moving forward toward the clinic. P. Jeffrey Conn, PhD, a member of the MJFF Scientific Advisory Board, heads one such effort, the Program in Translational Neuropharmacology and Drug Discovery at VanderbiltUniversity in Nashville, Tennessee.

“The Foundation recognizes the strengths beyond target identification that academic scientists bring to therapeutics discovery and development,” said Dr. Conn. “The drug development process is a constantly changing ecosystem, one in which a for-profit’s risk appetite necessarily rises and falls with access to capital. Academic institutions, being less subject to these kinds of economic shifts, often have latitude to advance discovery efforts for early and high-risk targets that industry would generally pass up until a later stage of development.”

“TDI was initially designed to capture the attention and imagination of industry decision-makers and put Parkinson’s more realistically and squarely in their sights,” said Todd Sherer, PhD, vice president of research programs at MJFF. “TDI awards serve to accelerate companies’ internal timelines and activate their ability to reach critical decision points for Parkinson’s disease projects. While supporting industry efforts remains a priority, we also recognize that today a great deal of exciting drug development research is being done in academic settings. We’re confident that by including a special funding track for academic researchers, we will only increase the quality and quantity of applications we receive.”

Under the 2008 TDIprogram, MJFF primarily seeks to support development of therapies that have the clear potential to provide a disease-modifying benefit (i.e., neuroprotection), something no currently available treatment can do, or to provide long-term and significant relief from PD symptoms above and beyond that offered by current therapies, including strategies to alleviate complications of current treatments such as dyskinesias (the disruptive movements that are a side effect of long-term levodopa use).The Foundation is also eager to support development of treatments that address ‘non-motor’ aspects of PD, such as cognitive dysfunction, depression, autonomic dysfunction and sleep disorders. In addition, MJFF is interested in novel and innovative therapeutic delivery platforms and technologies that can tackle key delivery barriers and safety concerns to greatly enhance ability of treatments to impact, target and treat PD.

The first two rounds of TDI were enthusiastically received by industry researchers and the scientific community at large. To date the Foundation has awarded nearly $8 million total under the initiative for 14 projects.